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Silicon Breast Implant Recall

Breast implants manufactured by Poly Implant Prothese (PIP) have been recalled due to an unauthorized silicone gel being used in the implants. The silicone gel was reported to damage the elastomer coating of the implant which could lead to it leaking and inflammatory reactions. The recall, issued last week, has lead to the shut down the manufacturing of the implants completely.

In June 2000, the U.S. Food and Drug Administration (FDA) issued a warning letter to PIP, citing multiple problems with the production of implants by the company. Ninety percent of the implants manufactured by PIP are exported, with an estimated 66 countries receiving them.

"Clinicians should not implant these devices and they should quarantine any stock," said Dr. Susanne Ludgate from the Medicines and Health care products Regulatory Agency (MHRA). "Patients who have concerns about their PIP silicone gel-filled breast implants should contact their breast implant surgeon."

An estimated 35,000 to 45,000 women who received a breast implant after 2001 may be affected by the PIP implant recall.